Standard: AAMI 8638
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS — EXTRACORPOREAL BLOOD CIRCUIT FOR HEMODIALYZERS, HEMODIAFILTERS AND HEMOFILTERS
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This International Standard specifies requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators (hereafter referred to as "the device") and (integral and non-integral) transducer protectors which are intended for use in hemodialysis, hemodiafiltration and hemofiltration.
This International Standard does not apply to:
— hemodialyzers, hemodiafilters or hemofilters;
— hemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform hemodialysis, hemodiafiltration, hemofiltration or hemoconcentration.
NOTE Requirements for hemodialyzers, hemodiafilters, hemofilters and hemoconcentrators are specified in ISO 8637.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 8638|
|Most Recent Revision:||YES|